Gg Clotrimazole Usp, 1%

Gg Clotrimazole Usp, 1%
SPL v2
SPL
SPL Set ID e673748f-d00b-4ce8-e053-2995a90a9220
Route
TOPICAL
Published
Effective Date 2020-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Bisulfite Ion Propylene Glycol Ceteth-20 Cetostearyl Alcohol Edetic Acid Water Chlorocresol Light Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-17

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

  • avoid contact with eyes.
Section 50570-1

Do not useon children under 2 years of age unless directed by a doctor.

Warnings

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails
Active Ingredient

Clotrimazole 1% (w/w)

Other Information

  • store between 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

Ceteth-20, Cetostearyl Alcohol, Chorocresol, Edetate Disodium, Light Mineral Oil, Propylene Glycol, Sodium Metabisulfite,Water

Principal Display Panel

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Structured Label Content

Uses
  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes.
Section 50570-1 (50570-1)

Do not useon children under 2 years of age unless directed by a doctor.

Purpose

Antifungal

Warnings

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails
Active Ingredient (Active ingredient)

Clotrimazole 1% (w/w)

Other Information (Other information)

  • store between 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

Ceteth-20, Cetostearyl Alcohol, Chorocresol, Edetate Disodium, Light Mineral Oil, Propylene Glycol, Sodium Metabisulfite,Water

Principal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Advanced Ingredient Data


Raw Label Data

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